Label: GREAT VALUE ORANGE SCENT- orange chloroxylenol soap
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Contains inactivated NDC Code(s)
NDC Code(s): 63691-033-10 - Packager: Sun Products Corporation
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 7, 2017
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ACTIVE INGREDIENT
Active ingredient
Chloroxylenol 0.30%
Keep out of reach of children. In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.
Directions wet hands and forearms. Apply 5 mL or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GREAT VALUE ORANGE SCENT
orange chloroxylenol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63691-033 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) D&C RED NO. 33 (UNII: 9DBA0SBB0L) EDETATE SODIUM (UNII: MP1J8420LU) ALCOHOL (UNII: 3K9958V90M) BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) SODIUM LAURYL SULFATE (UNII: 368GB5141J) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63691-033-10 709 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/01/2016 Labeler - Sun Products Corporation (070931480)